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Re: exwannabe post# 438255

Tuesday, 01/25/2022 6:54:07 AM

Tuesday, January 25, 2022 6:54:07 AM

Post# of 708881

I still doubt no SAP had ever been submitted.



well a biotech does NOT have to submit the SAP until the trial is unblinded
https://investorshub.advfn.com/boards/read_msg.aspx?message_id=167437009

The IA is much less detailed than an actual final analysis. All they look at is a basically TLD. While the SAP has to nail down all the secondary endpoints.



I agree with you on this but what if the FDA then disapproves of the SAP which comes after and they already analyzed the data? They have a huge chance of having to throw away the whole trial. So IA, analyzing with noin approved semi SAP, hey efficiency YYYAHOO, submitting SAP with FDA, FDA disapproves Bamm trial kaput. See?


As Senti's clipped post said, the "DMCA charter" would provide additional information for stat analysis. Who do you think these additional details were provided to, and why?



Not to the FDA. And now Im confused was there or was there not additional information for stat analysis?


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